FDA Fast Track Designation Granted to Ozuriftamab Vedotin (CAB-ROR2-ADC) for Patients with Recurrent or Metastatic SCCHN
“The FDA’s decision is an important recognition of the potential of our CAB-ROR2-ADC, ozuriftamab vedotin. There remains a significant unmet need in refractory head and neck cancer where previous treatments have failed and current outcomes are suboptimal with low response rates,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. “To date, ozuriftamab vedotin has shown promising clinical activity in treatment-refractory SCCHN patients who had a median of 3 prior lines of therapy. In addition, ozuriftamab vedotin continues to have a manageable safety profile with no new safety signals. We look forward to discussing with the FDA plans for a potential registrational trial in the second half of this year.”
Share:
More News
“We are excited to have restarted our Phase 2 study in presurgical triple-negative breast cancer. Triple-negative is a deadly and aggressive form of breast cancer, and patients having local disease currently undergo a harsh six-month regimen whereby a small percentage can die from the SOC before their surgery,” said Intensity
“TRAVERSE represents a potential breakthrough for both Allogene and the broader CAR T field,” said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene. “CAR T has transformed hematologic malignancies while solid tumors have remained one of the field’s most difficult challenges. When we designed ALLO-316 with the
“We continue to be very encouraged by the longer-term data from our Phase 2 J201 study, and today’s announcement marks a pivotal step forward in our mission to bring safusidenib as a comprehensive treatment option for patients with all types of IDH1-mutant glioma,” said David Hung, M.D., Founder, President, and
“As the data continue to mature, we are increasingly encouraged by the preliminary findings emerging from both cohorts, particularly the overall survival trends observed in the cohort with MGMT unmethylated glioblastoma,” said Niven R. Narain, Ph.D., President and CEO of BPGbio. “These findings further reinforce our belief that targeting mitochondrial